Gallium Ga 68-labeled PSMA-11 PET / CT or PET / MRI in Diagnosing Patients with Intermediate to High-Risk Prostate Cancer

Status: Active

Description

This phase I / II trial studies how well gallium Ga 68-labeled PSMA-11 positron emission tomography (PET) / computed tomography (CT) or PET / magnetic resonance imaging (MRI) work in diagnosing patients with intermediate to high-risk prostate cancer. Gallium Ga 68-labeled PSMA-11 is an imaging drug that binds to prostate tumor cells and can be imaged using PET. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET / CT and PET / MRI, may help find the presence of prostate cancer that has spread to other parts of the body.

Eligibility Criteria

Inclusion Criteria

  • Biopsy proven prostate adenocarcinoma
  • Planned prostatectomy with lymph node dissection
  • Intermediate to high-risk disease (as determined by elevated PSA [PSA > 10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors)
  • Diagnostic CT or MRI as part of the PET study or performed within one month of PSMA PET
  • Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
  • Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria

  • Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
  • Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy * Including focal ablation techniques (high-intensity focused ultrasound therapy [HiFu])
  • Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery
  • Contraindication to Lasix

Locations & Contacts

California

San Francisco
UCSF Medical Center-Mount Zion
Status: Active
Contact: Thomas Hope
Phone: 415-353-9437
Email: thomas.hope@ucsf.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Sensitivity, specificity, positive and negative predictive value of prostate-specific membrane antigen (PSMA) PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis.

II. Sensitivity, specificity, positive and negative predictive value of PSMA PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis using nodal regional correlation.

SECONDARY OBJECTIVES:

I. Sensitivity, specificity, positive and negative predictive value of PSMA PET for the detection of extra-pelvic nodal metastases, visceral metastases and osseous metastases compared to biopsy and imaging follow-up.

II. Safety.

TERTIARY OBJECTIVES:

I. Sensitivity, specificity, negative and positive predictive value for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the PSMA-11 PET.

II. One year prostate-specific antigen (PSA) progression free survival, comparing patients with and without pelvic nodal metastases.

III. Correlation between SUVmax from PSMA-11 PET and short axis diameter of nodal disease on cross sectional imaging correlate to presence of true pathology.

IV. Incidence of osseous and distant metastatic lesions.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 1-2 minutes. Beginning 50-100 minutes later, patients undergo PET/CT over 30-40 minutes or PET/MRI over 50-60 minutes.

After completion of study, patients are followed up for 1 day.

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Diagnostic

Lead Organization

Lead Organization
UCSF Medical Center-Mount Zion

Principal Investigator
Thomas Hope

Trial IDs

Primary ID 16559
Secondary IDs NCI-2018-00038
Clinicaltrials.gov ID NCT02919111